FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
90217–90240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 1998
MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM
K972207 · MSD
Medcomp
Gastroenterology & Urology · 256d
Cleared Feb 23, 1998
URINE SCREENING DEVICE
K972676 · JXA
Combact Diagnostic Systems , Ltd.
Microbiology · 222d
Cleared Feb 23, 1998
LOCATOR MODEL 4036
K972814 · DTB
Pacesetter, Inc.
Cardiovascular · 209d
Cleared Feb 23, 1998
SURGICAL VASCULAR CLAMP
K973080 · DXC
Walter Lorenz Surgical, Inc.
Cardiovascular · 189d
Cleared Feb 23, 1998
IRRIGATION BOTTLE
K973829 · JOH
Automatic Liquid Packaging, Inc.
Anesthesiology · 139d
Cleared Feb 23, 1998
4.0MM SIMPLER ONE THREADED DENTAL IMPLANT
K974401 · DZE
Vancouver Implant Resources, Inc.
Dental · 94d
Cleared Feb 23, 1998
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
K974559 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Feb 23, 1998
GREPAFLOXACIN, 5 MG, SENSI-DISC
K974578 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 77d
Cleared Feb 20, 1998
CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE
K963758 · CAC
Sorin Biomedical, Inc.
Anesthesiology · 520d
Cleared Feb 20, 1998
DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS
K963759 · CAC
Sorin Biomedical, Inc.
Anesthesiology · 520d
Cleared Feb 20, 1998
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
K972158 · MEB
Princeton Regulatory Assoc.
General Hospital · 256d
Cleared Feb 20, 1998
PRESSUREGUARD IV
K972486 · IKZ
Span-America Medical Systems, Inc.
Physical Medicine · 233d
Cleared Feb 20, 1998
CARDIO-CARD MANAGEMENT SYSTEM II
K972795 · DXN
Nasiff Assoc., Inc.
Cardiovascular · 207d
Cleared Feb 20, 1998
DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL
K972904 · JJY
Casco Standards
Microbiology · 198d
Cleared Feb 20, 1998
PRESSURE GUARD SITE SELECT (A)
K973169 · FNM
Span-America Medical Systems, Inc.
General Hospital · 179d
Cleared Feb 20, 1998
FACEPLATE ASSEMBLY
K974219 · LRB
Finetone Hearing Instruments
Ear, Nose, Throat · 102d
Cleared Feb 20, 1998
ABUTMENT - COMPLETE
K974280 · DZE
The Implant Center of the Palm Beaches
Dental · 107d
Cleared Feb 20, 1998
CHROMOPHARE D 500, CHROMOPHARE D 530
K974433 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 88d
Cleared Feb 20, 1998
ANATOM 1000 (A MINUS, A-)
K974455 · JAK
Analogic Corp.
Radiology · 87d
Cleared Feb 20, 1998
VNUS CLOSURE SYSTEM
K974521 · GEI
Vnus Medical Technologies, Inc.
General & Plastic Surgery · 80d
Cleared Feb 20, 1998
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
K974816 · LTJ
Beckman Instruments, Inc.
Immunology · 59d
Cleared Feb 20, 1998
NONWOVEN DRESSING
K974823 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 58d
Cleared Feb 20, 1998
SIMPLICARE THIN FILM WOUND DRESSINGS
K980209 · MGP
Hollister, Inc.
General & Plastic Surgery · 31d
Cleared Feb 19, 1998
MOBIMED SYSTEM, (PEGASUS AND POLARIS)
K973318 · MSX
Ortivus Us, Inc.
Cardiovascular · 168d